The present invention is directed to a clinical data aggregation platform (ClinDAP) for loading, aggregating, standardizing and presenting (using dashboards and charts) data from various source systems supporting clinical drug development processes.
The clinical and non-clinical data captured by the various systems supporting clinical trials (eDC, Lab, CTMS, IVRS/IWRs etc.) in an organization is highly fragmented. The high degree of variability in data is attributed due to things such as regulatory requirements for capturing data in EDC systems, study design, different technology vendors, etc. The data originating from these disparate systems and formats makes it quite challenging to combine and build comprehensive business intelligence.
The product stack of the present invention supports loading, standardizing and aggregating data from various clinical systems in a central data hub. The source data is standardized by leveraging CDISC SDTM format using a data standardization engine. These standardized data sets are exposed through dashboards, visualizations, risk triggers, etc. in the ClinACT product and a connector that enables to integrate with external leading BI tools and clinical data aggregation platform service layer.